Hydrocodone Bitartrate and Acetaminophen

Product NDC
67296-0299
11-digit product format
672960299
Labeler code
67296
Product ID
67296-0299_d5fbffb6-b2ae-2ecd-e053-2a95a90af4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040736
Marketing category
ANDA
Marketing start
2010-01-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0299-0Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET407
67296-0299-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET307
67296-0299-2Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET107
67296-0299-3Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET157
67296-0299-4Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET207
67296-0299-5Hydrocodone Bitartrate and Acetaminophen6 in 1 BOTTLETABLET67
67296-0299-6Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET507
67296-0299-7Hydrocodone Bitartrate and Acetaminophen4 in 1 BOTTLETABLET47
67296-0299-8Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET607
67296-0299-9Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0299HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]7Legacy NDC, 10 package rows20220120_41998448-c34b-3bcb-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN41998448-c34b-3bcb-e054-00144ff88e887
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD41998448-c34b-3bcb-e054-00144ff88e887
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY41998448-c34b-3bcb-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0299-06729602990040 TABLET in 1 BOTTLE (67296-0299-0) 40 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-16729602990130 TABLET in 1 BOTTLE (67296-0299-1) 30 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-26729602990210 TABLET in 1 BOTTLE (67296-0299-2) 10 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-36729602990315 TABLET in 1 BOTTLE (67296-0299-3) 15 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-46729602990420 TABLET in 1 BOTTLE (67296-0299-4) 20 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-5672960299056 TABLET in 1 BOTTLE (67296-0299-5) 6 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-66729602990650 TABLET in 1 BOTTLE (67296-0299-6) 50 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-7672960299074 TABLET in 1 BOTTLE (67296-0299-7) 4 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-86729602990860 TABLET in 1 BOTTLE (67296-0299-8) 60 tablet2010-01-180000-00-00NoNoCurrent
67296-0299-96729602990912 TABLET in 1 BOTTLE (67296-0299-9) 12 tablet2010-01-180000-00-00NoNoCurrent